The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Livogiva ( formerly PF 708 and Bonsity in the US), intended for the treatment of osteoporosis. The applicant for this medicinal product is Theramex Ireland Limited. Alvogen has exclusive rights to commercialize and manufacture PF 708 in the EU.
Livogiva will be available as a solution for injection (20 micrograms/80 microlitres). The active substance of Livogiva is teriparatide, the active aminoterminal fragment of human parathyroid hormone . It acts via the receptor for parathyroid hormone and has an anabolic effect on bone. Livogiva is a biosimilar medicinal product. It is highly similar to the reference product Forsteo (teriparatide), which was authorised in the EU on 10 June 2003. Data show that Livogiva has comparable quality, safety and efficacy to Forsteo.